HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LUCIENA safely and effectively. See full prescribing information for LUCIENA.

INDICATIONS AND USAGE

LUCIENA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION

100 mg orally once daily until disease progression or unacceptable toxicity .

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity:  LUCIENA (enasidenib) can cause fetal harm. Advise patients of the potential risk to a fetus and use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) are nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite .

DRUG INTERACTIONS

• Certain CYP1A2 and CYP2C19 Substrates:  Avoid concomitant use unless otherwise recommended in the Prescribing Information .

• Certain CYP3A Substrates:  Avoid concomitant use unless otherwise recommended in the Prescribing Information .

• Certain OATP1B1, OATP1B3, and BCRP Substrates:  Avoid concomitant use unless otherwise recommended in the Prescribing Information.

USE IN SPECIFIC POPULATIONS

Lactation:  Advise not to breastfeed .

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.